Composite interference screws and drivers

ABSTRACT

The present disclosure relates to an anchor. The anchor includes a suture bridge having a proximal end and distal end. The distal end of the suture bridge has a thickness greater than a thickness of the proximal end of the suture bridge. At least two ribs extend from the proximal end of the suture bridge to a proximal end of the anchor. At least one open helical coil wraps around the at least two ribs and extends, substantially, from the proximal end of the suture bridge to the proximal end of the anchor. The at least one open helical coil defines an internal volume communicating with a region exterior to the anchor through apertures between turns of the at least one open helical coil. The at least two ribs are engagable with a grooved shaft of a driver.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. application Ser.No. 13/787,139, filed Mar. 6, 2013, entitled COMPOSITE INTERFERENCESCREWS AND DRIVERS, which in turn is a continuation-in-part applicationof U.S. application Ser. No. 13/044,777, filed Mar. 10, 2011, which inturn claims priority to U.S. Provisional Application No. 61/312,291,filed Mar. 10, 2010, U.S. Provisional Application No. 61/334,808, filedMay 14, 2010, and U.S. Application No. 61/359,080, filed Jun. 28, 2010,the disclosures of which are incorporated herein by reference in theirentireties for all purposes.

BACKGROUND

Field of Technology

The present disclosure relates to medical apparatuses and procedures ingeneral, and more particularly to medical apparatuses and procedures forreconstructing a ligament.

Related Art

In many cases, ligaments are torn or ruptured as the result of anaccident. Accordingly, various procedures have been developed to repairor replace such damaged ligaments.

For example, in the human knee, the anterior and posterior cruciateligaments (i.e., the “ACL” and “PCL”) extend between the top end of thetibia and the bottom end of the femur. Often, the anterior cruciateligament (i.e., the ACL) is ruptured or torn as the result of, forexample, a sports-related injury. Consequently, various surgicalprocedures have been developed for reconstructing the ACL so as torestore substantially normal function to the knee.

In many instances, the ACL may be reconstructed by replacing theruptured ACL with a graft ligament. More particularly, in such aprocedure, bone tunnels are generally formed in both the top of thetibia and the bottom of the femur, with one end of the graft ligamentbeing positioned in the femoral tunnel and the other end of the graftligament being positioned in the tibial tunnel, and with theintermediate portion of the graft ligament spanning the distance betweenthe bottom of the femur and the top of the tibia. The two ends of thegraft ligament are anchored in their respective bone tunnels in variousways well known in the art so that the graft ligament extends betweenthe bottom end of the femur and the top end of the tibia insubstantially the same way, and with substantially the same function, asthe original ACL. This graft ligament then cooperates with thesurrounding anatomical structures so as to restore substantially normalfunction to the knee.

In some circumstances, the graft ligament may be a ligament or tendonwhich is harvested from elsewhere within the patient's body, e.g., apatella tendon with or without bone blocks attached, a semitendinosustendon and/or a gracilis tendon.

As noted above, various approaches are well known in the art foranchoring the two ends of the graft ligament in the femoral and tibialbone tunnels.

In one well-known procedure, which may be applied to femoral fixation,tibial fixation, or both, the end of the graft ligament is placed in thebone tunnel, and then the graft ligament is fixed in place using aheadless orthopedic screw, generally known in the art as an“interference” screw. More particularly, with this approach, the end ofthe graft ligament is placed in the bone tunnel and then theinterference screw is advanced into the bone tunnel so that theinterference screw extends parallel to the bone tunnel andsimultaneously engages both the graft ligament and the side wall of thebone tunnel. In this arrangement, the interference screw essentiallydrives the graft ligament laterally, into engagement with the opposingside wall of the bone tunnel, whereby to secure the graft ligament tothe host bone with a so-called “interference fit”. Thereafter, over time(e.g., several months), the graft ligament and the host bone growtogether at their points of contact so as to provide a strong, naturaljoinder between the ligament and the bone.

Interference screws have proven to be an effective means for securing agraft ligament in a bone tunnel. However, the interference screw itselfgenerally takes up a substantial amount of space within the bone tunnel,which can limit the surface area contact established between the graftligament and the side wall of the bone tunnel. This in turn limits theregion of bone-to-ligament in-growth, and hence can affect the strengthof the joinder. By way of example but not limitation, it has beenestimated that the typical interference screw obstructs about 50% of thepotential bone-to-ligament integration region.

For this reason, substantial efforts have been made to provideinterference screws fabricated from absorbable materials, so that theinterference screw can eventually disappear over time andbone-to-ligament in-growth can take place about the entire perimeter ofthe bone tunnel. To this end, various absorbable interference screwshave been developed which are made from biocompatible, bioabsorbablepolymers, e.g., polylactic acid (PLA), polyglycolic acid (PGA), etc.These polymers generally provide the substantial mechanical strengthneeded to advance the interference screw into position, and tothereafter hold the graft ligament in position while bone-to-ligamentin-growth occurs, without remaining in position on a permanent basis.

In general, interference screws made from such biocompatible,bioabsorbable polymers have proven clinically successful. However, theseabsorbable interference screws still suffer from several disadvantages.First, clinical evidence suggests that the quality of thebone-to-ligament in-growth is somewhat different than naturalbone-to-ligament in-growth, in the sense that the aforementionedbioabsorbable polymers tend to be replaced by a fibrous mass rather thana well-ordered tissue matrix. Second, clinical evidence suggests thatabsorption generally takes a substantial period of time, e.g., on theorder of three years or so. Thus, during this absorption time, thebone-to-ligament in-growth is still significantly limited by thepresence of the interference screw. Third, clinical evidence suggeststhat, for many patients, absorption is never complete, leaving asubstantial foreign mass remaining within the body. This problem isexacerbated somewhat by the fact that absorbable interference screwsgenerally tend to be fairly large in order to provide them with adequatestrength, e.g., it is common for an interference screw to have adiameter (i.e., an outer diameter) of 8-12 mm and a length of 20-25 mm.

Thus, there is a need for a new and improved interference fixationsystem which (i) has the strength needed to hold the graft ligament inposition while bone-to-ligament in-growth occurs, and (ii) promotessuperior bone-to-ligament in-growth.

SUMMARY

In one aspect, the present disclosure relates to an anchor. The anchorincludes a suture bridge having a proximal end and distal end. Thedistal end of the suture bridge has a thickness greater than a thicknessof the proximal end of the suture bridge. At least two ribs extend fromthe proximal end of the suture bridge to a proximal end of the anchor.At least one open helical coil wraps around the at least two ribs andextends, substantially, from the proximal end of the suture bridge tothe proximal end of the anchor. The at least one open helical coildefines an internal volume communicating with a region exterior to theanchor through apertures between turns of the at least one open helicalcoil. The at least two ribs are engagable with a grooved shaft of adriver.

In yet another aspect, the present disclosure relates to a deliverydevice and anchor combination. The delivery device of the combinationincludes a handle and shaft connected to the handle. The shaft includesa distal end having a slot and at least two grooves extending from theslot. The anchor of the combination includes a suture bridge having aproximal end and distal end. The distal end of the suture bridge has athickness greater than a thickness of the proximal end of the suturebridge. At least two ribs extend from the proximal end of the suturebridge to a proximal end of the anchor. At least one open helical coilwraps around the at least two ribs and extends, substantially, from theproximal end of the suture bridge to the proximal end of the anchor. Theat least one open helical coil defines an internal volume communicatingwith a region exterior to the anchor through apertures between turns ofthe at least one open helical coil. The anchor is located on the distalend of the delivery device such that the slot houses the proximalportion of the suture bridge and the at least two grooves engage the atleast two ribs of the suture bridge.

Further areas of applicability of the present disclosure will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the disclosure, are intended forpurposes of illustration only and are not intended to limit the scope ofthe disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthe specification, illustrate the embodiments of the present disclosureand together with the written description serve to explain theprinciples, characteristics, and features of the disclosure. In thedrawings:

FIG. 1 shows a first embodiment of the delivery device of the presentdisclosure.

FIG. 2 shows a side view of the shaft of the delivery device of FIG. 1.

FIG. 2A shows an exploded view of the distal end of the shaft of FIG. 2.

FIG. 3 shows a cross-sectional view of the shaft of FIG. 2.

FIG. 4 shows a front view of the distal end of the shaft of FIG. 2.

FIG. 5 shows an isometric view of the screw for use with the shaft ofFIG. 2.

FIG. 6 shows a side view of the screw of FIG. 5.

FIG. 7 shows a cross-sectional view of the screw of FIG. 6.

FIG. 8 shows a second embodiment of a shaft of the present disclosure.

FIG. 9 shows a side view of the inner member of the shaft of FIG. 8.

FIG. 9A shows an exploded view of the distal end of the inner member ofFIG. 9.

FIG. 10 shows a cross-sectional view of the inner member of the shaft ofFIG. 9.

FIG. 11 shows a front view of the distal end of the inner member of FIG.9.

FIG. 12 shows an isometric view of the outer member of the shaft of FIG.8.

FIG. 13 shows a cross-sectional view of the outer member of FIG. 12.

FIGS. 14 and 15 show side views of the shaft of FIG. 8 with the outermember in different positions.

FIG. 16 shows an isometric view of a third embodiment of a shaft of thepresent disclosure and a screw for use with the shaft.

FIG. 17 shows an isometric view of the shaft of FIG. 16.

FIG. 18 shows an isometric view of the screw of FIG. 16.

FIG. 19 shows a side view of the screw of FIG. 16.

FIG. 20 shows a cross-sectional view of the screw of FIG. 19.

FIG. 21 shows an isometric view of a fourth embodiment of a shaft of thepresent disclosure and a screw for use with the shaft.

FIG. 22 shows an isometric view of the screw of FIG. 21.

FIG. 23 shows an isometric view of the shaft of FIG. 21.

FIG. 24 shows an isometric view of the shaft of FIG. 21 and analternative screw for use with the shaft.

FIG. 25 shows a side view of the screw of FIG. 24.

FIG. 26 shows a cross-sectional view of the screw of FIG. 24.

FIG. 27 shows an isometric view of an example anchor with suture bridgeand example inserter shaft for the anchor.

FIG. 28 shows a side view of the shaft and anchor of FIG. 27.

FIG. 29 shows a cross-sectional view of FIG. 28.

FIG. 30 shows a close up view of the distal end of the anchor of FIG.29.

FIG. 31 shows a cross-sectional view of the anchor of FIG. 27.

FIG. 32 shows an isometric view of the anchor of FIG. 27.

FIG. 33 shows an isometric view of the shaft of FIG. 27.

FIG. 34 shows a cross-sectional view of an anchor inserted into bone.

FIG. 35 shows an isometric view of an example anchor with suture bridgeand proximal reinforcement.

FIG. 36 shows an isometric view of another example anchor with suturebridge.

FIG. 37 shows an isometric view of yet another example anchor withsuture bridge.

FIG. 38 shows a cross-sectional view of the anchor of FIG. 37.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the disclosure,its application, or uses.

FIG. 1 shows a first embodiment of the delivery device 10 of the presentdisclosure. The device 10 includes a handle assembly 11 and a shaft 12coupled to the handle assembly 11. The handle assembly 11 includes ahandle 11 a and a connector 11 b coupled to the handle 11 a. Theconnector 11 b has a channel 11 b′ and an opening 11 b″ to the channel11 b′. The opening 11 b″ is in the shape of a “D”. A proximal end 12 aof the shaft 12 is disposed within the channel 11 b′.

FIGS. 2, 2A, and 3-4 show the shaft 12. The shaft 12 includes a proximalend 12 a and a distal end 12 b. The proximal end 12 a is in the shape ofa “D” to match the shape of the opening 11 b″. The distal end 12 bincludes threads 12 c, grooves 12 d, and a depth stop 12 e. The grooves12 d extend a partial length of the shaft 12 and intersect the threads12 c. The depth stop 12 e is for use with a depth stop on a screw thatthe device 10 is used to implant into a bone tunnel during ligamentreconstruction surgery.

FIGS. 5-7 show the screw 20 for use with the delivery device 10 of thepresent disclosure. The screw 20 includes a proximal end 21 and a distalend 22. A majority of the screw 20 includes screw threads 23 in the formof an open helical coil, i.e. a connected series of continuous regularlyspaced turns extending in a helical or spiral form substantially fromthe proximal end 21 to the distal end 22 with apertures 24 being definedby the space between the turns of the coil. In other words, interferencescrew 20 may include an open helical coil defining an internal volume,with the internal volume communicating with the region exterior to theopen helical coil through the spacing between the turns of the openhelical coil. The distal end 22 also includes a depth stop 25 thatextends a partial length of the screw 20. The depth stop 25 includes aproximal end 25 a and a distal end 25 b. Additionally, a plurality oflongitudinally-extending runners 26 extend along the interior of thescrew threads 23.

The distal end 12 b of the shaft 12 is placed within the interior of thescrew 20, via the opening 27, until the proximal end 25 a of the depthstop 25 engages the depth stop 12 e of the shaft 12. During insertion ofthe shaft 12 into the screw 20, the runners 26 engage the grooves 12 dand become housed within the grooves 12 d. As shown in FIG. 1, thedistal end 12 b of the shaft 12 also includes hash marks 12 f, each ofwhich is associated with a number 12 g. Once the screw 20 is placed onthe shaft 12, the proximal end 21 of the screw 20 aligns with one of thehash marks/numbers 12 f, thereby indicating the length of the screw 20.

FIGS. 8, 9-9A, and 10-15 show an alternative shaft 30 of the presentdisclosure. The shaft 30 includes an inner member 31 and an outer member32 disposed over the inner member 31. The proximal end 31 a of the innermember 31 is similar in shape to the proximal end 12 a of the shaft 12.The distal end 31 b of the inner member 31 includes threads 31 c.Grooves 31 d extend along the member 31 and intersect the threads 31 c.Additionally, threads 31 e are located between the proximal and distalends 31 a,31 b of the member 31. The outer member 32 includes a firstsection 32 a and a second section 32 b. The first section 32 a has alarger diameter than the second section 32 b. The first section 32 aalso includes threads 32 c on an inner wall 32 d of the outer member 32.

Once the outer member 32 is disposed over the inner member 31, threads32 c engage threads 31 e to move the outer member 32 relative to theinner member 31. Moving the outer member 32 relative to the inner member31 allows for more or less of the distal end 31 b of the inner member 31to be shown. Similar to the distal end 12 b of the shaft 12, the distalend 31 b of inner member 31 includes hash marks/numbers (not shown) thatalign with an end 32 b′ of the second section 32 b, thereby indicating alength of screw 40 that will be disposed on the distal end 31 b of theinner member 31. As shown in FIGS. 14 and 15, the outer member 32 islocated at different positions along the length of the inner member 31to allow for screws 40 of different lengths to be loaded on the distalend 31 b of the inner member 31.

A handle assembly, similar to the handle assembly 11, is coupled to theproximal end 31 a of the inner member 31. Similar to screw 20, screw 40includes a proximal end 41 and a distal end 42. The screw 40 includesscrew threads 43 in the form of an open helical coil having an interiorand a plurality of longitudinally-extending runners 45 extending alongthe interior of the screw threads 43. Screw 40 is more fully describedin United States Patent Application Publication No. 20080154314, thedisclosure of which is incorporated herein by reference in its entirety.Once the outer member 32 has been moved to indicate the screw length,the screw 40 is loaded onto the distal end 31 b, such that a proximalend 41 of the screw 40 engages the end 32 b′ and the runners 45 engagethe grooves 31 d and become housed within the grooves 31 d.

FIGS. 16-20 show another alternative embodiment of the shaft 50 andscrew 60 of the present disclosure. The shaft 50 includes a firstportion 51 including a proximal end 51 a and a distal end 51 b and asecond portion 52 including a first area 52 a and a second area 52 b.The proximal end 51 a is configured to be coupled to a handle assembly,similar to the handle assembly 11. However, other handle assemblies maybe used. The first area 52 a has a smaller diameter than the firstportion 51, such that a first depth stop 51 b′ exists at the distal end51 b of the first portion 51. The second area 52 b has a smallerdiameter than the first area 52 a such that a second depth stop 52 cexists between the first area 52 a and the second area 52 b. An end 52b′ of the second area 52 b is tapered to allow for easier insertion ofthe anchor 60 into a bone during ligament reconstruction surgery, aswill be further described below. The second portion 52 also includesgrooves 53 extending between the first and second areas 52 a,52 b. Forthe purposes of this disclosure, there are three grooves 53. However,the second portion 52 may include a higher or lower number of grooves53.

Similar to screw 20 shown in FIGS. 5-7, screw 60 includes a proximal end61 and a distal end 62. A majority of the screw 60 includes screwthreads 63 in the form of an open helical coil, i.e. a connected seriesof continuous regularly spaced turns extending in a helical or spiralform substantially from the proximal end 61 to the distal end 62 withapertures 64 being defined by the space between the turns of the coil.In other words, interference screw 60 may include an open helical coildefining an internal volume, with the internal volume communicating withthe region exterior to the open helical coil through the spacing betweenthe turns of the open helical coil. The distal end 62 also includes adepth stop 65 that extends a partial length of the screw 60. The depthstop 65 includes a proximal end 65 a and a distal end 65 b. Unlike theopen depth stop 25 of screw 20 most clearly shown in FIG. 5, the depthstop 65 of screw 60 is a closed depth stop, most clearly shown in FIG.18. Additionally, a plurality of longitudinally-extending runners 66extend along the interior of the screw threads 63.

The second portion 52 of the shaft 50 is placed within the interior ofthe screw 60, via the opening 67, until the proximal end 65 a of thedepth stop 65 engages the second depth stop 52 c of the shaft 50. Duringinsertion of the shaft 50 into the screw 60, the runners 66 engage thegrooves 53 and become housed within the grooves 53. The screws 60 may beof a variety of lengths. For example, a screw 60 may be of such lengththat its proximal end 61 would engage the first depth stop 51 b′.

As described above, during ligament reconstruction surgery, the end ofthe graft ligament is placed in the bone tunnel and then theinterference screw 20,40,60 is advanced into the bone tunnel via the useof shafts 12,30,50 so that the interference screw 20,40,60 extendsparallel to the bone tunnel and simultaneously engages both the graftligament and the side wall of the bone tunnel. The screws 20,40,60 maybe used in either the femoral or tibial tunnels. Methods of ligamentreconstruction via use of the screws 20,40,60 is further shown in the'314 publication shown above.

FIGS. 21-23 show yet another alternative embodiment of the screw 100 andthe delivery device 200 of the present disclosure. The screw 100includes a proximal end 101 and a distal end 102. A majority of thescrew 100 includes screw threads 103 in the form of an open helicalcoil, i.e. a connected series of continuous regularly spaced turnsextending in a helical or spiral form substantially from the proximalend 101 to the distal end 102 with apertures 104 being defined by thespace between the turns of the coil. In other words, interference screw100 may include an open helical coil defining an internal volume, withthe internal volume communicating with the region exterior to the openhelical coil through the spacing between the turns of the open helicalcoil. The distal end 102 also includes a suture bridge 105 that extendsa partial length of the screw 100. The suture bridge 105 includes aproximal end 105 a and a distal end 105 b. The distal end 105 b includesa concave shape. A flexible member 110, such as a suture, is housedwithin the screw 100, such that the suture 110 extends around the distalend 105 b of the bridge 105. Additionally, longitudinally-extendingrunners 106 extend from the suture bridge 105 and along the interior ofthe screw threads 103. For the purposes of this disclosure, there aretwo longitudinally extending runners 106. However, more or less than tworunners are within the scope of this disclosure.

The delivery device 200 includes a distal end 201 having a slot 202 andgrooves 203 extending from the slot 202 on each side of the device 200.As shown in FIG. 21, the screw 100 is located on the distal end 201 suchthat the suture bridge 105 is housed within the slot 202 and the runners106 are housed within the grooves 203. The delivery device 200 iscannulated, such that when the screw 100 is located on the device 200,the suture ends 110 a,110 b extend through the cannulation 204.

FIGS. 24-26 show a screw 300 similar to screw 100. However, screw 300additionally includes a pointed tip 311 located on the distal end 302.The tip 311 includes a through hole 312. The hole 312 helps in locatingthe suture 110 within the interior of the screw 300. As shown in FIG.24, the screw 300 is located on the distal end 201 of delivery device200 such that the suture bridge 305 is housed within the slot 202 andthe runners 306 are housed within the grooves 203. As stated above, thedelivery device 200 is cannulated, such that when the screw 300 islocated on the device 200, the suture ends 110 a,110 b extend throughthe cannulation 204, as shown in FIG. 24.

For clarity purposes, only the distal end 201 of the device 200 isshown. However, the device 200 would include a proximal end, similar tothe devices above, which may be coupled to a handle assembly, similar tohandle assembly 11 above. The screws 100,300 are used in the repair ofsoft tissue, specifically to re-attach tissue to bone. One example ofthis repair is when the screw 100,300 is delivered into bone via the useof device 200, the device 200 is removed from screw 100,300, the tissueis placed on the bone to be adjacent the screw 100,300, the suture ends110 a,110 b are pulled through the tissue, and then the suture ends 110a,110 b are tied. A hole may be made in the bone prior to insertion ofthe screw 100,300 into the bone. However, screw 300 may be inserted intobone without first making a hole in the bone. In this case, the pointedtip 311 is used to start insertion of the screw 300 into the bone andthen rotary motion may be used to complete insertion of the screw 300into the bone. Other methods of tissue repair via use of these screwsand delivery device may also be used.

The handle 11 a of handle assembly 11 is made from plastic, however,other non-metal and metal materials may also be used. The shape and sizeof handle 11 a may be any shape and size necessary to help facilitateinsertion of the screw 20 into bone. The coupler 11 b is made from ametal material, such as stainless steel or titanium, but may be madefrom other metal and non-metal materials that are strong enough towithstand the forces applied during surgery. The coupler 11 b ispress-fit to the handle 11 a, but may be coupled to the handle 11 a inany other manner known to those of skill in the art. The size and shapeof the coupler 11 b may be any size and shape necessary to helpfacilitate insertion of the screw 20 into bone. The channel 11 b′ may beany length necessary and the opening 11 b″ may be any shape necessary tofacilitate coupling of the shaft 12 to the coupler 11 b.

The shaft 12 is made from a metal material, such as stainless steel andtitanium, however, other metal and non-metal materials that wouldwithstand the forces applied during surgery may be used. The diameter ofthe shaft 12 may vary. The proximal end 12 a of the shaft 12 may be anyshape necessary to facilitate insertion of the end 12 a through opening11 b″ and into channel 11 b′. The number of threads 12 c and grooves 12d may vary and the lengths of the grooves 12 d may also vary. Thelocation of depth stop 12 e may also vary based on the diameter of theshaft 12 and the diameter of the screw 20 that is used. The grooves 12d, depth stop 12 e, and threads 12 c may be formed by any method knownto one of skill in the art.

The screw 20 is made from a polymer material via a molding method.However, other material, which would allow the screw 20 to withstandforces applied during surgery, and other methods of making may be used.The depth stop 25 is open ended and doesn't extend the entire innerdiameter of the screw 20. The amount of screw inner diameter that thedepth stop 25 covers may vary and the length of the depth stop 25 mayvary based on the diameter of the screw. The number and length of therunners 26 may also vary. Once the screw 20 is located on the shaft 12,the distal end 12 b of the shaft 12 extends from the distal end 22 ofthe screw 20. During insertion of the screw 20 into bone, the threads 12c create threads in the bone, thereby creating a seat for the screwthreads 23, as described more fully in the '314 publication. The amountof the distal end 12 b of the shaft 12 that extends from the distal end22 of the screw 20 may vary.

The diameters of the first and second sections 32 a,32 b of outer member32 may vary and the number of threads 32 c may also vary. The number ofthreads 31 c,31 e and grooves 31 d may vary and the lengths of thegrooves 31 d may also vary. The inner and outer members 31,32 are madefrom a metal material, such as stainless steel and titanium, and via amethod known to one of skill in the art. However, other materials mayalso be used. The screw 40 is made from a polymer material via a moldingmethod. However, other material and methods of making may be used. Thenumber and length of the runners 45 may also vary. Once the screw 40 islocated on the shaft 30, the distal end 31 b of the shaft 30 extendsfrom the distal end 42 of the screw 40. During insertion of the screw 40into bone, the threads 31 c create threads in the bone, thereby creatinga seat for the screw threads 43, as described more fully in the '314publication. The amount of the distal end 31 b of the shaft 30 extendingfrom the screw 40 may vary.

The shaft 50 is made from a metal material, such as stainless steel ortitanium, but may be made from another metal material or a non-metalmaterial that is strong enough to withstand the force applied to theshaft 50 during surgery. The shaft 50 may be made via a method known toone of skill in the art. The diameters of the first and second portions51,52 may vary along with the number and lengths of the grooves 53 andthe locations of the depth stops 52 c,51 b′ may vary based on thediameter of the screw 60 or other factors. Rather than being tapered,the end 52 b′ may be designed in another manner to allow easierinsertion of the screw 60 into bone. The screw 60 is made from a polymermaterial via a molding method. However, other material, which wouldallow the screw to withstand the forces applied during surgery, andother methods of making may be used. The number and length of therunners 66 may also vary. Once the screw 60 is located on the shaft 50,the second portion 52 of the shaft 50 extends from the distal end 62 ofthe screw 60. The amount of the second portion 52 extending from thescrew 60 may vary. Additionally, the length of the depth stop 65 mayalso vary based on the diameter of the screw 60 or other factors.

The delivery device 200 is made from a metal material, such as stainlesssteel or titanium, but may be made from a non-metal material that isstrong enough to withstand the forces applied to the device 200 duringsurgery. The delivery device 200 is made via a method known to one ofskill in the art. The screws 100,300 are made from a polymer materialand via a molding process, however, other material, which would allowthe screw to withstand the forces applied during surgery, and otherprocesses known to one of skill in the art may be used. The suturebridge 105 may have a distal end 105 b having a shape other than concaveand the length of the suture bridge 105, the slot 202, and the grooves203 may vary. The size and the shape of the hole 312 may vary.

For example, FIGS. 27-33 show yet another alternative embodiment of ascrew (anchor) 400 and the delivery device 200 of the presentdisclosure. The screw 400 includes a proximal end 401 and a distal end402.

The distal end 402 also includes a suture bridge 405 that extends apartial length of the screw 400. The suture bridge 405 includes aproximal end 405 a and a distal end 405 b.

The distal end 405 b of the suture bridge 405 has a thickness greaterthan a thickness of the proximal end 405 a of the suture bridge 405. Inone example, the distal end 405 b includes a convex shape. A convenientexample of the screw 400 has a suture bridge with a bulbous profile. Aflexible member 410, such as a suture, is housed within the screw 400,such that the suture 110 extends around the distal end 405 b of thebridge 405.

A majority of the screw 400 includes screw threads 403 in the form of anopen helical coil, i.e. a connected series of continuous regularlyspaced turns extending in a helical or spiral form substantially fromthe proximal end 405 a of the suture bridge 405 to the proximal end 401of the screw 400 with apertures 404 being defined by the space betweenthe turns of the coil. In other words, the screw 400 may include an openhelical coil defining an internal volume, with the internal volumecommunicating with the region exterior to the open helical coil throughthe spacing between the turns of the open helical coil.

In one example of the screw 400, the screw threads 403 cover theproximal end 405 a of the suture bridge 405 (best seen in FIG. 30). Inanother example of the screw 400, the screw threads 403 start atproximal end 105 a of the suture bridge 105. In some examples, the screwthreads 403 may define, at least in part, an anchor body and may bereferred to as such.

Longitudinally-extending runners (ribs) 406 extend from the suturebridge 405 and along the interior of the screw threads 403. For thepurposes of this disclosure, there are two longitudinally extendingrunners 406. However, more or less than two runners are within the scopeof this disclosure.

The delivery device 200 includes a distal end 201 having a slot 202 andgrooves 203 extending from the slot 202 on each side of the device 200.As shown in FIG. 27, the screw 400 is located on the distal end 201 suchthat the proximal end 405 a of the suture bridge 405 is housed withinthe slot 202 and the runners 406 are housed within the grooves 203. Thedelivery device 200 is cannulated such that when the screw 400 islocated on the device 200, the suture ends 410 a, 410 b extend throughthe cannulation 204.

The general suture bridge design described above with reference to FIGS.27-33 may be advantageous to screws (anchors) made from bioabsorbablematerial. Compared to other materials, such as polyetheretherketone(PEEK), a bioabsorbable material is weaker and more brittle. Testingshows that other suture bridge designs, while adequate for devices madefrom PEEK, do not provide sufficient bridge strength for products madefrom bioabsorbable material.

FIGS. 28-31 show a convenient example of the suture bridge 405 suitablefor an open-architecture anchors (e.g., fenestrated anchor) fabricatedfrom bioabsorbable material.

FIG. 28 shows a working example of a device 400 in which a bulbousdistal end 405 b of the suture bridge 405 is outside an inserter 200.The foregoing arrangement allows additional space/volume for the suturebridge 405 to occupy and for the device 400 to still accommodate a fullsuture load.

FIG. 29 shows a cross section view of working end of the device 400—thesame section of the device depicted in FIG. 28. In this case, the crosssection is rotated 90 degrees. The bulbous distal portion 405 b of thesuture bridge 405 protrudes outside the inserter 200 and is enlarged tobetter distribute the load imparted onto the suture bridge 405 by asuture.

FIG. 30 shows a close up view of the distal end 402 of the device 400.The bulbous portion 405 b of the suture anchor 405 is outside theenvelope of the inserter 200. The extension of the bulbous portion 405 bof the bridge outside 405 of the inserter 200 allows there to be roomfor a suture 410 to occupy.

FIG. 31 shows a cross section view of the device 400 removed from theinserter 200. The bulbous portion 405 b of the suture anchor 405 can beseen, as can the interaction between the suture 410, suture bridge 405and the anchor body 403.

While the suture bridge 405 and its examples are described above in thecontext of a single suture, the foregoing disclosure also applies to adevice loaded with multiple sutures (e.g., three) and the associatedsuture load. Because the distal (thick) end of the suture bridge 405extends beyond the inserter 200, the suture bridge 405 is able toaccommodate a large suture load. Because the distal end 402 of thebridge 405 is bulbous, the suture bridge 405 can withstand significantloads applied by multiple sutures.

The general suture bridge design contemplates other variations providinga suture bridge that is structurally strong to hold up to loads impartedonto it by a suture(s), particularly during knot tying by a surgeon. Inone example, the bulbous portion of the suture bridge extends distallyfurther increasing the load carrying capability of the suture bridge. Inother example, the diameter of the suture bridge extends beyond thewidth of the longitudinal ribs/runners further enhancing the strength ofthe suture bridge.

FIG. 34 shows an anchor 500 inserted into bone 550. The anchor 500 holdsone or more sutures 555 used, for example, to tie soft tissue (notshown) down to the bone 550. The bone 550 has a hard outer layer ofcortical bone 560 and soft inner layer of cancellous bone 565. There maybe more layers of bone. The number of layers, however, is not importantto the following disclosure but rather there is one layer harder thanthe other. The hard outer layer of cortical bone or simply “corticallayer” 560 imparts a strong reactionary force on the anchor 500. It isobserved that this reactionary force is a cause of failure in anchors,particularly in anchors having an open-architecture design and made frombioabsorbable material, such as the examples described above withreference FIGS. 27-33.

In testing, open-architecture anchors made from bioabsorbable materialinserted into 25/5 pcf bilayer bone block simulating average humeralhead bone, exhibit a novel failure mode of thread stripping from theanchors. Failure of the threads initiates in the simulated corticallayer (25 pcf) and cascades down the anchors as each subsequent threadencounters the simulated cortical layer during a pullout event, such aswhen a surgeon tensions a suture to tie a knot. Failure initiates in thedistal most threads of the anchors because a disproportionately highamount of the (axial) load applied by the suture to the anchors isreacted by the distal most threads, which are embedded in the denser(harder) cortical layer. The failure of the distal most threads and thesubsequent cascade of thread failure lead to reduced fixation strengthof the anchors in average humeral head bone quality as represented by25/5 pcf bone block.

FIG. 35 shows an example of the anchor 500 designed to handle thereactionary force imparted by the cortical layer 560 and to prevent apullout failure. The anchor 500 includes a proximal end 501 and a distalend 502. The distal end 502 includes a suture bridge 505 that extends apartial length of the anchor 500, such as the suture bridge 405described above with reference to FIGS. 28-31.

A majority of the anchor 500 includes screw threads 503 in the form ofan open helical coil, i.e. a connected series of continuous regularlyspaced turns extending in a helical or spiral form substantially fromthe proximal end 505 a of the suture bridge 505 to the proximal end 501of the anchor 500. The terms screw threads and helical coil are usedinterchangeably herein. The anchor 500 includes apertures 504 beingdefined by the space between turns of the helical coil 503. The anchor500 is further characterized by a number of turns per a given length,called “screw thread pitch” or simply “pitch.”

At the proximal end 501 of the anchor 500, webbing 520 extends betweenadjacent turns 515 a and 515 b of the coil 503. The number of turns withwebbing in between is a function of the thickness of the cortical layer560 and the pitch of the helical coil 503. Because the anchor 500 (andits example) is reinforced, proximally, according to the foregoingrelationship, the inserted anchor 500 supports a greater axial load thancompared to non-reinforced anchors. The inserted anchor 500 (and itsexample) exhibits a greater resistance to being pulled out of bone or“pull out strength” than compared to anchors without proximalreinforcement, particularly, in the hard layer and soft layer makeupfound in typical humeral head bone stock.

In one example of the anchor 500, the number of turns with webbing inbetween increases as the thickness of the cortical layer 560 and/or thepitch of helical coil 503 increases.

As shown in FIG. 35, an example of the anchor 500 includes a proximalweb between the distal most thread 515 a and the second most distalthread 515 b. This example of the anchor 500 has a dual lead threadmeaning there are two “ridges” wrapped around the cylinder of the bodyof the anchor 500. With a dual lead thread arrangement, the web 520circumnavigates the proximal end 501 as shown. Because of the screwthread pitch of the anchor 500, the proximal web 520 extends through thefull cortical layer thickness of the humeral head bone stock providingreinforcement of the anchor through the entire cortical layer.

The example of the anchor 500 shown in FIG. 35 has one “distal” gapbetween the distal most thread 515 a and the second most distal thread515 b filled with webbing 520. Other examples of the anchor 500 may havemore than one distal gap between threads filled with webbing 520. Theextent the webbing 520 progresses distally down the anchor 500 is basedon the thicknesses of the cortical layer into which the anchor 500 is tobe inserted and the pitch of the anchor 500.

Some examples of the anchor 500 have different numbers of turnscorresponding to different cortical layer thicknesses. The thickness ofthe cortical layer varies from bone to bone, e.g., the cortical layer ofthe humeral head is thinner than the cortical layer of the tibia.Proximal reinforcement of the anchor 500 may be advantageously tailoredto a specific application e.g., the proximal reinforcement of an anchorused in shoulder repair is different than the proximal reinforcement ofan anchor used in knee repair.

FIG. 36 shows an example anchor 600 having a proximal end 601 and distalend 602. The anchor 600 includes, at the distal end 602, a suture bridge605 (such as one described above with reference to FIGS. 27-31). Theanchor 600 further includes two open helical coils 603 a, 603 b in adual lead thread arrangement. The two open helical coils 603 a, 603 bextend from the suture bridge 605 toward the proximal end 601. Webbing620 extends between adjacent turns of one of the two helical coils. Theconfiguration of the anchor 600 strengthens/reinforces a substantiallength of the anchor 600, including the entire length. At the same time,the configuration of the anchor 600 provides a degree of opennesspromoting desirable bony ingrowth. It may be convenient in some examplesof the anchor 600 to characterize the webbing 620 as being continuous(i.e., continuous webbing).

FIGS. 37 and 38 show an example anchor 700 having a proximal end 701 anddistal end 702. The anchor 700 includes, at the distal end 702, a suturebridge 705 (such as one described above with reference to FIGS. 27-31).A majority of the anchor 700 includes a plurality of regularly spacedturns 703 extending in a helical or spiral form from a proximal end 705a of the suture bridge 705, approximately, to the proximal end 701 ofthe anchor 700. Webbing 720 extends between each turn of the pluralityof regularly spaced turns 703 and an adjacent turn (e.g., turns 703 aand 703 b). The webbing 720 gives the anchor 700 torsion and compressionstrength. The webbing 720 defines apertures 722, which may berectangular (square) or oval (circle) in shape. The apertures 722 givethe anchor 700 a degree of openness promoting desirable bony ingrowth.It may be convenient in some examples of the anchor 700 to characterizethe webbing 720 as being interrupted or perforated (i.e.,interrupted/perforated webbing).

As various modifications could be made to the exemplary embodiments, asdescribed above with reference to the corresponding illustrations,without departing from the scope of the disclosure, it is intended thatall matter contained in the foregoing description and shown in theaccompanying drawings shall be interpreted as illustrative rather thanlimiting. Thus, the breadth and scope of the present disclosure shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims appendedhereto and their equivalents.

What is claimed is:
 1. An anchor comprising: a suture bridge having aproximal end and distal end, the distal end of the suture bridge havinga thickness greater than a thickness of the proximal end of the suturebridge and defining the distal terminus of the anchor; at least two ribsextending from the proximal end of the suture bridge to a proximal endof the anchor; and at least one open helical coil wrapping around the atleast two ribs and extending, substantially, from the proximal end ofthe suture bridge to the proximal end of the anchor, the at least oneopen helical coil defining an internal volume communicating with aregion exterior to the anchor through apertures between turns of the atleast one open helical coil; wherein the at least one open helical coiland the proximal end of the suture bridge define a space extending to aregion adjacent the distal end of the suture bridge, the spaceconfigured for receipt of a distal end of a delivery device, such thatthe distal end of the suture bridge projects beyond the distal end ofthe delivery device.
 2. The anchor of claim 1 wherein the suture bridgehas a bulbous profile.
 3. The anchor of claim 1 wherein the distal endof the suture bridge is convex in shape.
 4. The anchor of claim 1wherein the at least one open helical coil covers the proximal end ofthe suture bridge.
 5. The anchor of claim 1 wherein the anchor is madefrom a bioasborable material.
 6. The anchor of claim 1 furthercomprising, at the proximal end of the anchor, webbing extending betweenadjacent turns of the at least one helical coil, a number of turns withwebbing in between configured to be a function of the thickness of thecortical layer of bone and the pitch of the at least one helical coil.7. The anchor of claim 6 wherein the number of turns with webbing inbetween is configured to increase with an increase in the thickness ofthe cortical layer of bone, increase in the pitch of the at least onehelical coil, or an increase in both.
 8. The anchor of claim 6 whereinthe anchor includes two open helical coils in a dual lead threadarrangement, and wherein the webbing extends between adjacent turns ofone of the two helical coils.
 9. The anchor of claim 6 wherein the atleast one open helical coil includes a plurality of regularly spacedturns; and wherein the webbing extends between each pair of turns anddefines openings through which the internal volume of the anchorcommunicates with the region exterior to the anchor.
 10. The anchor ofclaim 1, further comprising at least one suture routed over the distalend of the suture bridge, such that the at least one suture projectsbeyond the distal end of the delivery device.
 11. The anchor of claim 1,wherein a diameter of the suture bridge extends beyond a width of the atleast two ribs.